MoCRA Compliance Guide for Small Cosmetics Manufacturers (2026)

If you make lip balm, lotion, soap, or any cosmetic product to sell in the US, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) probably applies to you. It’s the biggest expansion of FDA’s authority over cosmetics since 1938 — and understanding what it requires is less complicated than the legislation makes it sound.

This guide breaks down what MoCRA means for small cosmetics manufacturers: the requirements that are already in effect, the deadlines still ahead, and whether your business qualifies for exemptions.

Last updated: March 2026

Quick MoCRA Compliance Checklist for Small Makers

Before we get into the details, here’s a snapshot of what you need to know:

• Facility registration — register your manufacturing facility with the FDA (due July 2024, renewals every two years)
• Product listing — list every cosmetic product you sell with the FDA, updated annually
• Adverse event reporting — report serious health events to the FDA within 15 business days
• Safety substantiation — maintain records proving your products are safe
• Labeling — ensure your labels include accurate ingredients and contact information
• GMP — Good Manufacturing Practice rules are coming (not yet finalized, see timeline below)
• Small business exemption — businesses under $1M in annual sales may be exempt from some of these (see Am I Exempt? below)

MoCRA Compliance Timeline

Not everything in MoCRA hit at once. The FDA has been rolling out requirements in phases — and some are still pending. Here’s where things stand:

Already in Effect

Still Ahead

The GMP regulations have been significantly delayed. The FDA was originally expected to propose GMP rules by December 2024 and finalize them by December 2025. Neither deadline was met, and the rulemaking has been pushed to a “long-term action” in the FDA’s Unified Agenda. That said, the existing adulteration provisions under the FD&C Act still apply — which means you should be following good manufacturing practices regardless.

What MoCRA Requires

Here’s what each key requirement actually means for your business:

Adverse Event Reporting

If your product causes a serious adverse health event, it must be reported to the FDA within 15 business days. Any additional information about the event should also be submitted within 15 business days of receipt.

This is where good batch tracking and lot number records become critical. If the FDA comes knocking about a particular product, you need to be able to trace exactly which ingredients went into which batch, and when it was made.

Facility Registration

Every facility that manufactures or processes cosmetic products for the US market must register with the FDA and renew this registration every two years. If a product from your facility is found to pose a serious health risk, the FDA can suspend your registration.

Product Listing

Every cosmetic product on the market must be listed with the FDA. This listing should include the product’s ingredients and must be updated annually.

Safety Substantiation

You’re required to ensure the safety of your products and maintain records proving it. The law doesn’t specify which tests to use — but your supporting data needs to come from scientifically sound methods.

Good Manufacturing Practice (GMP) Requirements

The FDA will eventually establish formal GMP requirements for cosmetics facilities. While the timeline has slipped (see above), the smart move is to start aligning with ISO 22716 — the international standard the FDA has repeatedly signaled it will reference.

Read more: GMP for Small Manufacturers - A Simple Guide

Labeling Requirements

Your product labels must be accurate and adhere to FDA’s labeling regulations. This includes listing all ingredients in descending order of concentration, proper usage instructions, contact information for the responsible person, and any necessary warnings. As of December 2024, contact information is mandatory on all cosmetic labels.

Product Recalls

The FDA has the authority to recall cosmetic products from the market if there’s a safety issue. You need proper procedures in place for handling recalls — including the ability to trace affected batches back to their ingredients.

Third-Party Certification

MoCRA allows third-party certification as a way to demonstrate compliance. This can be helpful for small manufacturers who don’t have the resources to conduct every test and evaluation in-house.

Am I Exempt from MoCRA?

This is the question most small makers have — and the answer depends on your revenue and what you make. Here’s a simple way to think about it:

The Decision Tree

Step 1: Check your revenue Do you have average annual gross US sales of cosmetic products under $1 million (averaged over the past three years)?

• No → Full MoCRA compliance applies.
• Yes → Move to Step 2.

Step 2: Check your product types Do you manufacture any of the following?

• Products that contact mucous membranes of the eye (e.g., eye makeup, contact lens solutions)
• Injectable cosmetics
• Products intended for internal use

• Products that alter appearance for more than 24 hours where removal by the consumer isn’t typical (e.g., semi-permanent dyes, lash extensions)

• Yes to any → Full MoCRA compliance applies, regardless of revenue.
• No → You likely qualify for the small business exemption.

What the Exemption Covers

If you qualify, you’re exempt from:

• Facility registration with the FDA
• Product listing with the FDA
• Good Manufacturing Practices (when finalized)
• Reduced adverse event recordkeeping — 3 years instead of the standard 6

What You’re Still Required to Do

Even exempt businesses must:

• Report serious adverse events to the FDA within 15 business days
• Ensure product safety (safety substantiation still applies)
• Follow labeling requirements (including the new contact information requirement)
• Comply with recall orders if the FDA identifies a safety issue

You don’t need to file paperwork to claim the exemption — but keep your sales records in case the FDA asks.

Cosmetic Ingredient Review (CIR) Program

The CIR program reviews the safety of cosmetic ingredients and publishes regular reports on its findings. As a small cosmetics manufacturer, staying current with CIR publications helps ensure your formulations use ingredients that are considered safe under current scientific review.

Seeking Further Assistance on MoCRA

For manufacturers seeking more information, several resources are available:

• FDA Office of Cosmetics and Colors — the primary regulatory body, with FAQs, fact sheets, and direct support
• Personal Care Products Council (PCPC) — the leading national trade association, offering guidance on regulatory and compliance issues
• FDA’s MoCRA overview page — the definitive source for current deadlines and guidance documents

For tailored legal advice, consider consulting with an attorney specializing in FDA regulations and cosmetics compliance.

How MoCRA Software Helps You Stay Compliant

If this all feels like a lot of paperwork, you’re not alone. The real challenge with MoCRA isn’t understanding the rules — it’s maintaining the records that prove you’re following them. That’s where purpose-built MoCRA software makes a real difference.

Specialized inventory software can automate the tracking that MoCRA demands: product batches, ingredient sourcing, manufacturing dates, and the complete audit trail you need for adverse event reporting and recalls. Instead of juggling spreadsheets and hoping you can piece together which ingredients went into which batch, you have everything in one place.

Meet Craftybase — inventory and manufacturing software designed for small cosmetics manufacturers. Craftybase helps you:

• Track raw materials from purchase to finished product with full batch traceability
• Maintain lot number records that satisfy FDA audit requirements — see our guide on lot numbers for cosmetics
• Monitor stock levels in real time so you know exactly what’s on hand
• Generate cost reports so you know your true product costs
• Create a clear audit trail that’s invaluable during regulatory reviews or inspections

Think of it as your compliance safety net. When the FDA asks for records, you’re not scrambling — you’re pulling up a report.

Ready to see how it works? Start a free trial today and take the first step toward stress-free MoCRA compliance.

Frequently Asked Questions